The mechanism behind this problem is the sutures placed in the pubocervical fascia during the cystocele repair. The cited benefit of bladder plication is greater cure of cystocele. The existence of pubocervical fascia and the need for placement of plicating sutures over the bladder have been questioned.

The objective of this study is to determine if avoiding cystocele plication in women undergoing surgery for cystocele decreases the need of catheterization beyond post operative day #2.

We will conduct a RCT of patients undergoing transvaginal repair of midline cystocele at the Mount Sinai Hospital. Patients will be randomized to receiving plicating sutures versus no plication. This procedure may be conducted with or without concomitant correction of other sites of prolapse. However, they will not have any procedures for correction of stress incontinence.

This study will be powered to detect a reduction in voiding dysfunction from 50% to 25% of patients. Using a χ2 distribution, and an alpha error of 0.05, the required sample size is 58 patients per group.

A secondary outcome will be intraoperative ureteric obstruction. All patients, regardless of study arm, will undergo intraoperative cystoscopy following intravenous administration of indigo carmine in order to identify this complication. If this complication does occur the suspected plicating suture(s) will removed, replaced more centrally, and cystoscopy repeated to ensure ureteric permeability.

Patients between 18 and 75 years, who will undergo surgery at the Mount Sinai Hospital that includes cystocele repair, will be eligible.

Exclusion Criteria:

Patients will be excluded if the surgeon places anterior vaginal mesh or a mid-urethral sling, and/or if they had prior surgery for anterior vaginal wall prolapse and/or stress urinary incontinence.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01197248